SPY411.49+2.97 0.73%
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Lilly Highlights Presentation Of Patient-Reported Outcomes From Phase 3 monarchE Trial For Verzenio At St. Gallen Virtual Congress 2021

PRO data further support the monarchE results to date for Verzenio for the treatment of HR+, HER2- high risk early breast cancer First disclosure of patient-reported outcomes for a Phase 3 study of a CDK4 & 6

· 03/17/2021 06:50


PRO data further support the monarchE results to date for Verzenio for the treatment of HR+, HER2- high risk early breast cancer
First disclosure of patient-reported outcomes for a Phase 3 study of a CDK4 & 6 inhibitor in the adjuvant setting for HR+, HER2- early breast cancer

INDIANAPOLIS, March 17, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) today announced patient-reported outcomes (PRO) for the investigational use of Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC). The PRO analysis included patients in both arms of the study and measured their experiences with side effects, symptoms, and health-related quality of life, in those receiving Verzenio plus ET versus ET alone. In one analysis, the PRO data indicated that most patients (approximately 70-75%) in both arms reported being bothered "a little bit" or "not at all" by treatment-related side effects. This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects. The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference.

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 percent compared to ET alone – a statistically significant improvement in invasive disease-free survival for HR+, HER2- high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). 

"The patient-reported outcomes analysis represents another step forward in our understanding of the impact for patients who receive abemaciclib in the early breast cancer setting," said Dr. Sara M. Tolaney, MD, MPH, Harvard Medical School, Dana-Farber Cancer Institute. "These important data demonstrate actual patient-reported outcomes, which are the first to be reported for a CDK4 & 6 inhibitor in the early breast cancer setting. These analyses continue to reaffirm our confidence in abemaciclib, and its potential to make a difference for those with high risk early breast cancer."

PROs were assessed at randomization, during treatment (3 months onwards) and in the follow-up period (safety population, n=5591). Overall, patient compliance for PROs was greater than 90 percent. Expectedly, patient-reported diarrhea was more common in patients receiving Verzenio plus ET. Most patients who experienced diarrhea while receiving Verzenio plus ET reported having diarrhea "a little bit" or "somewhat." Health-related quality of life, patient-reported endocrine symptoms and fatigue, as well as patient responses to items reflecting hot flushes, arthralgia and fatigue were similar between treatment arms. With the exception of diarrhea, the addition of Verzenio to ET did not result in any clinically meaningful differences in the PROs. The PRO poster was selected for one of the three St. Gallen International Breast Cancer Conference Poster Awards 2021.

The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints. The abstracts presented at St. Gallen will be published in a supplement issue of The Breast, available on March 17, 2021. A list of the data presentations, along with the viewing details, are highlighted below.

Verzenio (abemaciclib):

  • Abstract # P008: Patients' quality of life and side effect perceptions in monarchE, a study of abemaciclib plus endocrine therapy in adjuvant treatment of HR+, HER2-, node-positive, high risk, early breast cancer (Sara M. Tolaney)
    • Accepted as ePoster – Adjuvant Systemic Therapy
    • Available on-demand on March 10, 2021
    • Selected for one of the three St. Gallen International Breast Cancer Conference Poster Awards 2021
  • Abstract # P013: Safety outcomes from monarchE: Phase 3 study of abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER-2-, node-positive, high risk, early breast cancer (Hope S. Rugo)
    • Accepted as ePoster – Adjuvant Systemic Therapy
    • Available on-demand on March 10, 2021